Advice You - Business

It is clear that good Corporate Governance is in the best interests of shareholders of public companies, but

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

how can it benefit shareholders of private companies and other business owners?

Will a good system of corp

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

orate governance increase the bottom line?

One of the elements of a good system of corporate governance is

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ensuring that the role, and the boards' expectations, of management are understood.

Separation

Separation

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of the board and management is often lacking when it comes to small medium sized enterprises. Often senior c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ompany managers are also members of the board, hence the board may be deprived of one of its most critical r

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

oles, the ability to review and direct.

It is this element of corporate governance, through use of independ

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ent directors, that can help a business improve both its corporate governance and profitability.

Influence

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

The influence that a board has on an organisation is dependent both on the skills and knowledge of the dire

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ctors and the role that the board chooses to take.

Inevitably a board of well chosen directors will add to

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

company's focus and create additional business opportunities.

Three roles

Generally there are three gener

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ic roles which boards tend to take:

The Watchdog - total supervisory role
The Trustee - evaluation of

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

business and guidance
The Pilot - actively directs the business

As there is no "one size fits al

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

l" solution to corporate governance business owners need to consider their current situation before embarkin

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

g on structural change in the name of Corporate Governance.

Independent directors

The appointment of indep

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

endent directors to a board will often involve a shift in thinking for many small businesses operators but i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

t is important to explore some of the benefits which independent directors may bring to a business. These us

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ually include:

- Generation of new ideas - Signal to external parties that the business is becoming inves

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

tor ready - Renewed focus on strategic business issues.

It is through such advantages that the business m

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ay benefit both internally and externally from the improved Corporate Governance that will inevitably follow

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice You - Corporate Governance for Business Owners

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